RA&QA Manager (Surgical Device)
Job Title: | RA&QA Manager (Surgical Device) |
Contract Type: | Permanent |
Location: | Hong Kong |
Industry: | Healthcare & Life Sciences |
Reference: | 60031_1726718319 |
Contact Name: | Stanley Leung |
Contact Email: | stanley.leung@kos-intl.com |
Job Description
About Our Client
Our client is an international market leader in the medical industry. To cope with their further expansion in APAC, they would like to invite a high calibre individual to join their professional team as a Quality Assurance and Regulatory Affairs Manager.
About the Role
- Leading the QA/RA department to ensure quality excellence in accordance with local compliance and regulatory standards
- Coordinates R&D and clinical activities in accordance with specific registration information
- Oversees product registration as per design changes and renewal, and to closely liaises with regulatory authority on regulatory affairs
- Manage document life cycle and integrity of QA files for efficient record-keeping and retrieval
- Support internal and external audit and inspections
- Drive post-market surveillance such as CAPA, NC, and FSCA activities. Work with other departments in case of product issue management, and to ensure that regulatory clearances are obtained in a timely manner
- Perform ad-hoc activities as per urgent decisions
The successful applicant
- Bachelor degree in clinical science, engineering, pharmacy or other relevant disciplines
- A minimum of 8 years of experience in medical device regulatory, R&D, diagnostics, life science or biotechnology sector
- Analytical, attentive and organized with good problem-solving and project-management skills, able to facilitate communication across different departments
- Candidate with knowledge in APAC, EU and other regulatory compliance would be of great advantage, Candidate with experience in RA/QA management would be of advantage
- Candidates with less experience would be consider as Senior RA/QA executive
Click "Apply Now" to apply for this position or call Stanley Leung at +852 3180 4931 for a confidential discussion. All information collected will be kept in strict confidence and will be used for recruitment purpose only.
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